Inflammatory Bowel Disease 5CONUTNCT06648551
Diagnostic Performance of Controlling Nutritional Status as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease 5, run by Hospital General de Mexico at 1 site in Mexico.
Trial summary
The objective of this observational study is to determine the diagnostic performance of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease. The main questions to be answered are: What is the sensitivity and specificity of CONUT as a nutritional screening tool in patients with… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease 5
- What is being tested?
- CONUT
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 28 Oct 2023to 28 Oct 2027
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ulcerative Colitis patients
Who may be able to join
- Age 18 years and older
- Gender unspecified
- Histologically confirmed Ulcerative Colitis
- Diagnosis confirmed by a specialist physician
Who cannot join
- Patients with any amputation or prosthesis
- Patients with a pacemaker
- Patients with any neoplasm
- Pregnancy or lactation
- With comorbidities such as diabetes, hypertension, heart failure, thyroid problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Nallely Hernandez Bueno
Mexico City, Cuauhtemoc, 06720
Nalllely Bueno Hernandez, PhD, 27892000 ext. 5654, nallely_bh5@yahoo.com.mx
Viridiana M Mendoza Martinez, B.S., 5529370762, dinvestigacionhgm@gmail.com
About this study
Official title: Diagnostic Performance of CONUT as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease
The objective of this observational study is to determine the diagnostic performance of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease. The main questions to be answered are:
What is the sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease?
The participants will:
Undergo body composition analysis and a medical history review to understand the characteristics of their current condition, apply the GLIM criteria, and conduct their nutritional assessment.
- Conditions
- Inflammatory Bowel Disease 5
- Being tested
- CONUT
- Medical subject headings
- Inflammatory Bowel Disease 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONUTDiagnostic test
It is a scale that uses albumin, lymphocytes, and cholesterol for the diagnosis of malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic test
sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start28 Oct 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion28 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease 5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nallely Bueno Hernández, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648551
- Sponsor's protocol ID
- DI/23/501/03/31
- Acronym
- CONUT
- Status last verified
- Oct 2024
- First submitted
- 8 Jul 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of CONUT as a Nutritional Screening Tool in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06648551
- Acronym / sponsor ID
- CONUT / DI/23/501/03/31
- Conditions
- Inflammatory Bowel Disease 5
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 28 Oct 2027 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this observational study is to determine the diagnostic performance of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease. The main questions to be answered are:
What is the sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease?
The participants will:
Undergo body composition analysis and a medical history review to understand the characteristics of their current condition, apply the GLIM criteria, and conduct their nutritional assessment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ulcerative Colitis patients
Key inclusion criteria (4 listed)
- Age 18 years and older
- Gender unspecified
- Histologically confirmed Ulcerative Colitis
- Diagnosis confirmed by a specialist physician
Key exclusion criteria (5 listed)
- Patients with any amputation or prosthesis
- Patients with a pacemaker
- Patients with any neoplasm
- Pregnancy or lactation
- With comorbidities such as diabetes, hypertension, heart failure, thyroid problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONUTIt is a scale that uses albumin, lymphocytes, and cholesterol for the diagnosis of malnutrition | Diagnostic test | – |
Primary outcome
Diagnostic test
Time frame: one year
sensitivity and specificity of CONUT as a nutritional screening tool in patients with Inflammatory Bowel Disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease 5, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic test (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.